NCT01192698

Brief Summary

The main goal of this study is to prevent liver allograft infection with Hepatitis C virus in hepatitis C positive patients undergoing liver transplantation. The hypothesis is that patients who receive ribavirin immediately before transplant and intravenous interferon alfa 2b during the anhepatic phase(while the liver is removed)will have sustained virologic response post liver transplant.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

August 7, 2017

Completed
Last Updated

April 21, 2022

Status Verified

July 1, 2017

Enrollment Period

3.3 years

First QC Date

August 30, 2010

Results QC Date

August 1, 2014

Last Update Submit

April 19, 2022

Conditions

Hepatitis CCirrhosis

Keywords

cirrhosishepatitis C

Outcome Measures

Primary Outcomes (1)

  • HCV RNA Result

    Will measure mean HCV RNA levels 4 weeks after liver transplant

    4 weeks after liver transplant

Study Arms (2)

IV interferon

EXPERIMENTAL

IV interferon oral ribavirin

Drug: IV interferon

Standard of care

NO INTERVENTION

standard of care

Interventions

IV interferonDRUG

IV interferon 5MU during anhepatic phase

IV interferon

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • liver transplant for hepatitis c

You may not qualify if:

  • allergy to interferon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis CFibrosis

Interventions

Interferons

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Limitations and Caveats

small sample size short duration of treatment

Results Point of Contact

Title
Dr. Mark W. Russo
Organization
Carolinas Medical Center
mark.russo@carolinashealthcare.org
704-355-6649

Study Officials

  • Mark W Russo, MD, MPH

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2010

First Posted

September 1, 2010

Study Start

October 1, 2009

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

April 21, 2022

Results First Posted

August 7, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share